Reducing Acute Kidney Injury in TAVI Patients (REDUCE Trial)
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 入组人数
- 136
- 试验地点
- 1
- 主要终点
- Reduction of acute kidney injury (stage 1 or above) at 48-72 hours.
研究概览
简要总结
Evaluating whether forced diuresis with matched hydration will reduce the risk of contrast induced nephropathy in patients undergoing Transcatheter Aortic Valve Implantation (TAVI).
详细描述
Reducing Acute Kidney Injury in TAVI Patients (REDUCE trial)
The Effect of the Forced Diuresis With Matched Hydration in Reducing Acute Kidney Injury During Transcatheter Aortic Valve Implantation (TAVI)
Interventional Cardiology, Department of Cardiology Tel Aviv Medical Center Tel Aviv Sackler Faculty of Medicine, Tel Aviv University Introduction
Hypothesis: RenalGuard system will reduce the incidence of acute kidney injury in TAVI patients.
Aim: To assess the efficacy of treatment with the RenalGuard system compared to common practice using infusion of normal saline and N-acetylcysteine.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Triple (Participant, Care Provider, Investigator)
入排标准
- 年龄范围
- 65 Years 至 —（Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Subject is 65 years old who is able and willing to give an informed consent.
- •Patients undergoing planned trans-femoral TAVI.
- •Calculated eGFR below 60ml/min/1.73m2 (MDRD)
排除标准
- •History of acute coronary syndrome in the past 30 days.
- •History of congesting heart failure with left ventricular ejection fraction <30% or exacerbation in the past 30 days.
- •Current dialysis treatment.
- •Known furosemide hypersensitivity.
- •Contraindications to placement of a Foley catheter in the bladder.
研究组 & 干预措施
Renal Guard
Renal Guard in addition to Saline and N-Acetylcysteine
干预措施: Renal Guard (Device)
Renal Guard
Renal Guard in addition to Saline and N-Acetylcysteine
干预措施: Conventional Treatment (Drug)
Conventional Treatment
Saline and N-Acetylcysteine
干预措施: Conventional Treatment (Drug)
结局指标
主要结局
Reduction of acute kidney injury (stage 1 or above) at 48-72 hours.
时间窗: 48-72 hours
we will measure the incidence of VARC-2 acute kidney injury at 48-72 hours.
次要结局
- the RenalGuard system will lower 30 day readmission rate(2 years)
- whether endothelial function assessment can predict AKI AKI.(2 years)
- Prevention of AKI according to chronic statin treatment(2 years)
- Predictive power of abnormal carotid doppler results and AKI incidence(2 years)
- Predictive power of different biomarkers for predicting AKI and outcome(2 years)
- Whether the RenalGuard system can lower major adverse clinical events (MACE) defined as a composite of all-cause mortality, myocardial infarction, AKI, 30 day readmission rate, and dialysis.(2 years)
- the RenalGuard system can lower 30 day congestive heart failure exacerbation rate(2 years)
研究者
michal roll
VPRD
Tel-Aviv Sourasky Medical Center